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DHS 281.021Recalls & reported problems

Synthes GmbH · 130 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM · Class 2 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982176462), received between May 10, 2018 and Oct 5, 2020 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • No Code Available1
  • Unspecified Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT HARDWARE REMOVAL DUE TO PROXIMAL FEMUR FRACTURE LOSS OF REDUCTION WITH DYNAMIC HIP SCREW SYSTEM (DHS) + CANNULATED SCREW AND WAS REVISED TO TOTAL HIP. THE PROCEDURE OUTCOME AND PATIENT'S STATUS ARE UNKNOWN. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 130 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM THIS IS REPORT 1 OF 4 FOR (B)(4).

    Patient problems: No Code Available

    MAUDE report 10628936 ↗
  • InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT REMOVAL OF ONE (1) DYNAMIC HIP SCREW (DHS) / DYNAMIC CONDYLAR SCREW (DCS) ONE-STEP LAG SCREW, ONE (1) 130 DEGREE DHS PLATE-STANDARD BARREL 2-HOLES/46 MM, AND ONE (1) UNKNOWN TRAUMA CORTEX SCREW ON (B)(6) 2018 DUE TO RETURN OF BENIGN NEOPLASM (TUMOR) AND SUSPECTED INFECTION. THE CONSTRUCT WAS INITIALLY IMPLANTED ON (B)(6) 2018. THE REMOVAL PROCEDURE INCLUDED USE OF A CEMENT SPACER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH PATIENT OUTCOME REPORTED AS OK. THIS REPORT IS FOR A 130 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46 MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Patient problems: Unspecified Infection

    MAUDE report 7501970 ↗

Other APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices

All APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.